Craig Stobie, Head of the Global Life Sciences Team at Domino says serialisation will make life harder for counterfeiters
As we welcome in 2015 we edge ever closer to the EU Falsified Medicines Directive (FMD)’s deadline for compliance. Despite a recent deadline extension to 2018, for most countries in the EU, manufacturers who do not yet have a solid plan must put this at the top of their 2015 resolutions.
Pressure continues to mount across Europe to ensure production lines are compliant in preparation for what may be the single greatest and most wide-reaching challenge the pharmaceutical industry has ever faced – the change from batch level to item level identification and managing the vast amounts of data this will create.
The fundamental premise of legislation in Asia, Europe, South America and the USA is the same – item level serialisation – to ensure the safety of medicines at a time when falsified products are being discovered at an increasingly dramatic rate. As the World Health Organization said in 2011, Internet sales and an increasing international trade of pharmaceuticals is allowing counterfeit medicines to enter the supply chain with worrying ease. To put this into perspective, a 2013 report by the Royal Pharmaceutical Society (RPS) stated 15 known major incidents of falsified medicines entering the UK between 2005 and 2011. Nine of these medicines were recalled, although it remains unclear what proportion of those medicines were returned, and in one incident alone, over half a million packs of counterfeited medicines remained in the hands of patients. Incidents like this are a stark reminder of how incredibly important safe-guarding legislation such as the EU FMD is in ensuring we are protected.
To comply, many manufacturers are looking to incorporate new equipment into their current systems. As a minimum, this new equipment must be compatible in order to ensure that downtime is minimised during installation and print quality and speed is optimised – potentially leading to benefits in overall equipment effectiveness (OEE) management. For generics and research-based manufacturers alike, when it comes to data handling, working with experienced suppliers who are already supporting hundreds of manufacturers with their compliance programmes across Europe will be of immense benefit. Suppliers who run partner programmes and offer joint counsel to manufacturers give the advantage of ensuring machinery is integrated at all areas of the line and beyond, ensuring customers are ready to handle the vast data pool that is looming and that lines are working as flawlessly as can be.
So as we cross the threshold into 2015 and with exact details of regulations due to be confirmed later this year, we have the opportunity to get ahead and ensure that as part of the EU, and as a sovereign nation in itself, the UK becomes the safest place to take medicines. Despite the huge task still ahead, once the legislation comes into force all stakeholders in the supply chain will be able to authenticate a product, right back to its point of manufacture. Medicines are currently the second-largest category of falsified items imported into Europe so serialisation can only be a good thing, as the very act makes life that much harder for counterfeiters.
Governments and manufacturers believe that nothing should stand between a patient and the medicines they require. The impending Directive means we minimise this risk, protecting our health and wellbeing and ensuring everyone is confident that the medicines they receive from pharmacies and hospitals are safe. So, in the war against counterfeiters and as manufacturers across the globe gear up for the new era of patient safety, are you up for the challenge?
